Subscribe to RSS
DOI: 10.1055/s-0033-1352952
Leukocytes decline > 2500/µl during Peginterferon Alfa-2B (PEG-2B)/Ribavirin (RBV) treatment predicts favorable SVR rates in difficult-to-treat patients with HCV Genotype 1 (G1) infection in real-life
Background and aims: Leukocyte decline during antiviral treatment of chronic HCV infection may reflect pharmacodynamic effects of pegylated interferons. We therefore investigated the possible association between leukocyte decline and SVR in difficult-to-treat patients (pts) undergoing Peg2b/RBV therapy for HCV G1 infection in real-life.
Methods: Data from the German Peg2b/RBV observational study were retrospectively analyzed. This real-life cohort study assessed the safety and efficacy of treatment of G1 infection with Peg2b 1.5 µg/kg/week + weight-based RBV (800 – 1200 mg/day) for up to 48 weeks at 285 sites. SVR was defined as undetectable serum HCV-RNA 24 weeks after end of treatment.
Results: 1.890 pts with G1 infection (44.1 ± 12.3yrs, female 43%, BMI 25.3 ± 4.7, baseline viral load of ≥600,000 IU/ml in 52.2%) had baseline and at least one leukocyte measurement during therapy. Overall, SVR following Peg2b/RBV treatment was 42.3%. A significant difference in SVR rates was observed between pts with maximal leukocyte decline > 2.500/µL (45.6%) and pts with leukocytes declines ≤2.500/µL (32.7%, Table). Higher SVR rates in pts with leukocyte declines > 2.500/µL were significantly (p = 0.0067) associated with lower non-response rates of 32.0% (458/1430) compared to 39.1% (164/419) in pts with a leukocyte decline ≤2.500/µL, while relapse rates did not differ (22.5% vs. 23.0%, p = 0.87). Leukocyte declines > 2.500µL were significantly associated with higher SVR rates in difficult-to-treat pts, such as pts ≥50yrs or pts with high baseline viral load.
Maximal leukocyte decline |
|||
SVR,% (n/N) |
≤2500/µl |
> 2500/µl |
P |
Overall |
32.7 (137/419) |
45.6 (652/1430) |
< 0.0001 |
Female |
36.7 (72/196) |
51.1 (309/605) |
0.0005 |
Male |
29.1 (65/223) |
41.6 (343/825) |
0.0007 |
Age < 50 years |
35.8 (88/246) |
48.9 (480/982) |
0.0002 |
Age ≥50 years |
28.3 (49/173) |
38.4 (172/448) |
0.0188 |
LVL < 600.000 IU/ml |
38.8 (73/188) |
55.9 (356/637) |
< 0.0001 |
HVL ≥600.000 IU/ml |
26.4 (57/216) |
37.3 (279/747) |
0.0029 |
Conclusions: A leukocyte decline > 2.500/µL predicts favorable SVR rates in difficult-to-treat patients undergoing Peg2b/RBV treatment for chronic HCV G1 infection in real-life. In general, leukocyte decline as pharmacodynamic Peg2b effect seems to reflect its antiviral activity.